a phase 3 clinical trial for a rabies vaccine (vero cell) for human use in healthy chinese subjects

Conditions: Rabies

Summary: the purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (vero cell) for human use in healthy chinese subjects aged 10-60 years, according to the essen methods (1-1-1-1-1) vaccination.

there will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. all of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional essen methods (1-1-1-1-1) vaccination.

Eligibility criteria:
inclusion criteria: * aged from 10 to 60 years old * subjects or legal guardians can and will comply with the requirements of the protocol * subjects or legal guardians are able to understand and sign the informed consent * healthy subjects judged from medical history after investigator's inquiry * subjects with temperature \<=37.0°c on axillary setting exclusion criteria: * female in lactation or pregnancy, or plan to be pregnant during the study period * subject who has allergic history to any vaccine or other medicines * subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine * subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain * subject with congenital malformation, developmental disorder or serious chronic disease * subject with autoimmune diseases or immunodeficiency * subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids * subject with diabetes (type i or ii) excluding gestational diabetes * subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease * subject with severe angioedema in the past 3 years or require treatment in the past 2 years * subject with hypertension and with a blood pressure exceeding 145/95 mmhg at enrollment time * subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder * subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period * subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years * asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation * guillain-barre syndrome * any prior administration of immunodepressant or corticosteroids in last 6 months * any prior administration of blood products in last 3 months * any prior administration of other research medicine/vaccine in last 30 days * any prior administration of any attenuated live vaccine in last 30 days * any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine * ongoing anti-tuberculosis prevention or treatment * subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years * any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent